New momentum on PrEP, but critical needs are overlooked

Originally appeared on the Huffington Post.

Last week, the World Health Organization (WHO) issued new comprehensive guidelines for addressing HIV/AIDS in so-called “key populations” — the current global health lingo for often-marginalized populations that are heavily affected by the AIDS epidemic including gay men and other men who have sex with men, people in prison, people who inject drugs, sex workers and transgender people.

While the guidance had a number of new recommendations, the one that has received — and deserves — the most attention is the recommendation that gay men and other MSM be offered the option of oral PrEP (the use of a daily medication to reduce risk of HIV infection) as part of comprehensive HIV prevention services. It’s the first time that this new strategy has received an unqualified endorsement from WHO, and it is a most welcome development!

Unfortunately, it also highlights the work that global health agencies and funders have, to date, left undone to make the world a place where such a recommendation could be put into practice. It also risks limiting PrEP’s future impact. By inadvertently reinforcing perceptions that this option is just for gay men, the recommendation could slow efforts to deliver it to others, including millions of heterosexual women at risk for HIV.

These new WHO recommendations come two years after that agency issued guidance on PrEP demonstration projects in low-resource settings, and the US Food and Drug Administration (FDA) approved the use of daily Truvada as PrEP in the US.

The 2012 WHO guidance and FDA approval opened a new chapter in the global rollout of this effective prevention strategy, and they sent a critical message: PrEP is real, it works, and it should be made available now. The 2014 WHO recommendation on PrEP for MSM reinforces that message, and that is a good thing.

But PrEP is an option for many people, not only for gay men. (It isn’t for everybody, of course, but that is a decision to be made by individuals and their health providers.) Global health leaders should be working, now, to develop and fund programs to provide access for anyone who can benefit. Oral PrEP should be integrated into comprehensive, high-impact prevention programs for all people at risk internationally, with particular attention to key populations but also for young women and married women who continue to bear the brunt of the epidemic.

WHO needs to quickly issue guidance on PrEP for all of the populations that can benefit. The data are strong enough to warrant this move, as the US Centers for Disease Control and Prevention recently showed with its guidance that recommended that doctors consider oral PrEP for anyone at high risk of HIV infection. State and local health agencies, including in New York State, are currently conducting demonstration studies to figure out how best to get PrEP to those who need it.

Public health history tells us that a broad recommendation can actually help ensure that specific populations get access. When the hepatitis B vaccine was introduced in 1986, it was recommended only for specific populations, which ended up stigmatized the intervention. It wasn’t until it was repositioned as being a health tool for the general population that it took off.

This lesson should be borne in mind, particularly in light of the homophobic climates in many African countries with high rates of new infections in MSM, women and youth. If PrEP is viewed mainly as an option for MSM, country authorities could be resistant to providing access for anyone.

The scientific evidence of PrEP is as strong in other populations, including heterosexual women and men, and people who inject drugs. Clinical trials in multiple countries have shown that people who consistently take PrEP with oral TDF alone or in combination with emtricitabine (FTC), also known as Truvada, can reduce their risk of becoming HIV-infected by 90 percent or more.

Here in the United States, PrEP is gaining momentum, as are efforts to begin to deliver PrEP to all of the populations that can benefit.. And while gay men have been the most vocal users of PrEP so far, others are beginning to benefit. The poignant accounts by PrEP users and providers at myprepexperience.blogspot.com and just this week on the cover story of New York magazine offer hope that this new strategy will save and improve many lives, just as researchers and advocates have long hoped.

If the rest of the world follows America’s lead, PrEP could become an important global health success story. It is already being rolled out faster than earlier public health advances, from vaccines to tampons, oral contraceptive pills and the female condom — many of which took decades to get into the field. To realize PrEP’s potential, several specific things need to happen now.

In addition to expanded WHO guidance, Gilead Sciences Inc., the maker of Truvada, needs to move swiftly to secure regulatory approval in countries where PrEP is most needed. This starts with the countries that hosted clinical trials, where, tragically, PrEP is now out of reach. In two of those countries, South Africa and Thailand, Gilead recently filed for approval. This is an important and welcome step but the process needs to happen much faster and in more places. That requires both more aggressive efforts by Gilead and the willingness of national regulatory authorities to quickly review and approve the company’s applications.

Global health programs, including PEPFAR and the Global Fund, need to help countries design PrEP programs that meet the needs of their populations. A key part of this process is to launch large-scale demonstration studies in a wide range of countries and populations. Those studies can help planners understand how best to target PrEP to the people who need it most, and how to address key challenges like ensuring that people adhere to their daily medications. But so far, few of these studies outside the US have been launched or even planned.

Finally, global funders need to put substantial resources into well-planned PrEP programs. In particular, PEPFAR and the Global Fund should make sure that PrEP is not squeezed out by other funding priorities. National health authorities, who are increasingly and importantly taking ownership of their HIV prevention funding, also need to ensure a place for this intervention.

PrEP is not the perfect or only solution to the global AIDS epidemic — in fact, there is not, and never will be, such a silver bullet. We need integrated and sustained combination prevention and treatment programs. And oral PrEP as an option for all people at risk must be part of that. For the millions of people who stand to benefit from oral PrEP, let’s treat it like the advance and opportunity that it is.

Px Wire: Making sense of the AIDS Conference, updated PrEP guidelines and contraceptive research

This latest issue of Px Wire comes out on the eve of the International AIDS Conference in Melbourne, Australia—and we begin with “AVAC’s Take” on key messages and commitments to look for at and after the meeting. The bottom line: turn talk into action.

 This means building on the recent UNAIDS definition of what ending AIDS means and when it should happen, and it means getting specific about how to turn guidelines into public health programs for impact.

Click here to download.

As Px Wire went to press, the World Health Organization launched new comprehensive guidance for HIV prevention and treatment for key populations. This includes a strong recommendation for offering oral PrEP in programs for gay men and other men who have sex with men (MSM). This development drew headlines and has the potential to expand access to strategic prevention for individuals who need it most. But as we note in our “Data Dispatch”, there are still only two demonstration projects ongoing in Africa—one of the geographies where gay men and other MSM have high rates of HIV—usually in the context of low levels of services and human rights protections. Without a clear plan for a suite of projects that answer key questions about PrEP in MSM as well as other populations who can benefit from PrEP, the new WHO guidance will not have the impact it should.

Px Wire also provides an update on the proposed ECHO trial, which seeks to measure the impact of different family planning methods on women’s risk of HIV. Originally set to test four contraceptive methods, the most recent trial protocol has just three arms—a change that reflects challenges fundraising for this research.

Our centerspread, features our redesigned website—including searchable databases, an infographics galley and our new blog, P-Values.

When do you stop an HIV prevention trial for futility? A primer for HIV prevention advocates

This fact sheet looks at why trials are stopped early for “futility.” What does this mean, when is such a recommendation made and how does it affect other ongoing trials?

Jeff McConnell Memorial Webinar – Audio

This webinar memorialized pioneering sociologist Jeff McConnell and his impact on HIV prevention science. Updates were presented on pre-exposure prophylaxis (PrEP) research and the implications of Dr. McConnell’s research on sexual networks for how PrEP will be implemented.Find details, slides and full flash webinar here.

HIV Prevention Europe Webinars: Rectal microbicides

The seventh webinar in our series addressing a range of topics in HIV prevention research, hosted jointly by NAM and AVAC, focused on rectal microbicides. Speakers included: Ian McGowan, University of Pittsburgh; Carolina Herrera, Imperial College; Alex Carballo-Dieguez, Columbia University; and Marc-André LeBlanc, IRMA.

The presentation was followed by a Q&A session. Click here for slides and audio from the webinar.

Will a pill a day prevent HIV? Anticipating the results of the tenofovir “PrEP” trials

This 2005 report examines the issues surrounding the tenofovir trials and makes recommendations for ensuring that trials are carried out ethically and that provisions are made for dealing with the results of the trials when they are available. The report also calls for more concerted coordination and advance planning to accelerate evaluation, licensing, and access to PrEP.

Ongoing and Planned PrEP Demonstration and Implementation Studies

This is a summary table of ongoing and planned global PrEP evaluation studies.

US CDC Releases New Clinical Guidelines for PrEP

The guidelines, the first national guidelines for PrEP use, provide instructions for health providers about providing daily TDF/FTC as PrEP for individuals at “substantial risk for HIV infection”; visit PrEP Watch to learn more about the guidelines, download materials and more.

And a group of 164 leading HIV/AIDS and health organizations today reiterated their strong support for oral PrEP as an important HIV prevention strategy for men and women at risk of HIV infection. The diverse group of advocates, researchers and service providers hailed new HIV PrEP guidelines from the US Centers for Disease Control and Prevention (CDC) as a science-driven, public health approach to what remains a major health crisis in the United States.

View the document here.

AIDS Vaccine Science for Busy Advocates – Current AIDS Vaccine R&D Pipeline

One-pager reviewing what we’ve learned from previous efficacy trials, the product pipeline and where we are today and future directions toward finding a vaccine that works.

Pre-Exposure Prophylaxis: An introductory factsheet

This introductory 2-page document defines PrEP, reviews the scientific evidence to date, and outlines key research, regulatory and advocacy issues going forward. This factsheet is part of a series on emerging HIV prevention strategies.